A Topical Antiseptic Bundle for Decreasing Surgical Site Infection in Head and Neck Cancer Patients: Perioperative Effects on the Oral Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Oral microbial abundance in preoperative samples measured by quantitative bacteriology.
研究概览
简要总结
This is a single-arm prospective trial of an intra- and postoperative topical antiseptic bundle. The study will recruit patients undergoing an open surgical resection of the upper aerodigestive tract requiring a planed vascularized reconstruction, which may be either pedicled and/or free flap. The objectives are to evaluate antimicrobial effects of a perioperative topical antiseptic bundle and to identify the source of surgical site infection as well as the rate of 30-day adverse events in head and neck cancer.
详细描述
The study design is a single-arm prospective trial. It will investigate the microbial effects of topical antisepsis on upper aerodigestive tract and reconstructive surgery in head and neck cancer patients. The primary hypothesis is that topical antisepsis will significantly decrease oral bacterial load and the presence of pathogenic organisms. Secondary outcomes will include identification of the source of the infectious bacterial organisms, surgical and non-surgical site infections, serious topical antisepsis-related complications, serious adverse events, and hospital revisits. The study populations will include head and neck cancer patients age 18 or greater undergoing head and neck reconstructive surgery in which there is a communication between the upper aerodigestive tract and the cervical skin which requires a planned vascularized reconstruction, either a regional pedicled flap or a free tissue transfer. The accrual goal will be 25 patients. Data collection will occur in both the inpatient and outpatient settings. Patients will be enrolled during their preoperative clinic visit. Each patient will be followed for study outcomes until 30 days postoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Planned to undergo an open surgical procedure requiring a communication between the upper aerodigestive tract and cervical skin with a planned vascularized reconstruction, which may be either a regional pedicled and/or free flap.
- •Subsites reconstructed must include at least one of the following: oral cavity, oropharynx, larynx, hypopharynx, and/or cervical esophagus.
- •Eligible patients must be undergoing surgery related to treatment for head and neck cancer. This includes immediate reconstruction after tumor ablation as well as reconstruction for delayed cancer-related indications including radionecrosis or improvement in functional outcomes after head and neck cancer treatment.
- •Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
排除标准
- •True allergy to any study-related medications
- •Active infection at the time of surgery
- •Pregnancy or actively breastfeeding mothers. Female subjects who are both lactating and breastfeeding or of childbearing potential who have a positive serum test during screening.
- •Patients incarcerated in state or federal penitentiaries
- •Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study.
结局指标
主要结局
Oral microbial abundance in preoperative samples measured by quantitative bacteriology.
时间窗: Baseline (immediately preoperative)
Bacteria will be measured as colony forming unit/mL.
Oral microbial abundance in preoperative samples measured by 16s sequencing.
时间窗: Baseline (immediately preoperative)
This will be measured by the number of operational taxonomic units.
Oral microbial abundance in intraoperative samples prior to antiseptic irrigations measured by quantitative bacteriology.
时间窗: During surgery before wound irrigation
Bacteria will be measured as colony forming unit/mL.
Oral microbial abundance in intraoperative samples prior to antiseptic irrigations measured by 16s sequencing.
时间窗: During surgery before wound irrigation
This will be measured by the number of operational taxonomic units.
Oral microbial abundance in samples after intraoperative antiseptic irrigations measured by quantitative bacteriology.
时间窗: During surgery following wound irrigation
Bacteria will be measured as colony forming unit/mL.
Oral microbial abundance in samples after intraoperative antiseptic irrigations measured by 16s sequencing.
时间窗: During surgery following wound irrigation
This will be measured by the number of operational taxonomic units.
Oral microbial abundance in postoperative samples measured by quantitative bacteriology.
时间窗: Postoperative day 3.
Bacteria will be measured as colony forming unit/mL.
Oral microbial abundance in postoperative samples measured by 16s sequencing.
时间窗: Postoperative day 3.
This will be measured by the number of operational taxonomic units.
次要结局
- The number of subjects with surgical site infection(30 days)
- Number of subjects with 30-day hospital revisits(Up to 30 days)
- Number of subjects with non-surgical site infections(30 days)
- The number of subjects with serious topical antisepsis-related complications(30 days)
研究者
Joseph Zenga
Assistant Professor
Medical College of Wisconsin